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510(k) Data Aggregation

    K Number
    K211577
    Device Name
    SoftFix Balloon Trocar
    Manufacturer
    Unimax Medical Systems Inc.
    Date Cleared
    2021-11-05

    (168 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Unimax Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SoftFixTM Balloon Trocar have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments into the body cavity of patients.
    Device Description
    The SoftFix™ Balloon Trocar is a series of sterile and single-use Trocar intended to be included as an extension to the previously cleared Unimax Trocar Series. In general, the Trocars from Unimax Trocar Series consist of an Obturator and a Cannula containing a seal system. The Obturator is used to place the cannula through the incision site into the patient's body cavity where the Cannula remains anchored at a desired position. For that anchoring purpose, previously cleared Trocars belonging to the Unimax Trocar Series are equipped with threaded Cannulas or Cannulas with a movable bolster. As a series extension, the Cannulas belonging to the SoftFix™ Balloon Trocars are now available with an inflatable balloon and a manually movable bolster to provide stabilization and minimize the fascial trauma during an endoscopic procedure. Whereas these Cannulas are also designed to be compatible with the Obturators belonging to the previously cleared Trocars from the Unimax Trocar Series. The balloon and movable bolster combination on the cannula come with two options; - a) "SoftFix™ Balloon Fixation Ring" combination - b) "SoftFix™ Balloon Fixation Cone" combination Similar to Cannulas of the Trocars from the Unimax Trocar Series, each Cannula of the SoftFix™ Balloon Trocars is a combination of a sleeve and a housing, fitted with a pair of seal and valve to maintain pneumoperitoneum when the Obturator or other laparoscopic devices are inserted or withdrawn through it during the surgical procedures. The Cannula also contains a stopcock with rotation valve at its proximal end in order to allow or prevent passage of any insufflation gas (e.g. CO2), when needed. Near the stopcock, the Cannula contains an inflation port to inflate/deflate the balloon using a standard syringe. While the movable "fixation ring" can be slid down the Cannula sleeve to adjust its height as well as fixing the Cannula at a desired position, the height of the "fixation cone" can be adjusted by pressing the thumb notch present on it and the Cannula can be anchored at the desired position by affixing fascial sutures on the struts present near the thumb notch.
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